Spatiotemporal Stereotactic Body Radiation Therapy for the Treatment of Patients With Polymetastatic Solid Tumors

NCT05733949 | Recruiting DMC

• 3 other identifiers: 22277NCI-2023-00245P30CA033572
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial evaluates the safety and effectiveness of spatiotemporal stereotactic body radiation therapy (ST-SBRT) in treating patients with solid tumors that have spread to other parts of the body (polymetastatic). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. ST-SBRT is designed to deliver radiation directly to the core of the tumor, while keeping the radiation exposure of the area around the tumor at minimal dosage.

Conditions

Metastatic Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Toxicity is defined as non-hematologic toxicity that is at least grade 3 (Common Terminology Criteria for Adverse Events version \[v\]5.0) and at least possibly related to the study treatment.

  Within 3 months after the last spatiotemporal stereotactic body radiation therapy (ST-SBRT) fraction

• Effectiveness of ST-SBRT

  Efficacy (corresponding to local treatment effect) is defined as a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within an irradiated lesion, as detected by computed tomography (CT) scan 4 weeks after any ST-SBRT fraction and compared against the baseline CT scan performed prior to any study treatment.

  4 weeks after any ST-SBRT fraction

Secondary Outcomes (8)

• Screen failures

  Up to 1 year

• Number of ST-SBRT fractions received, per subject

  Up to 1 year

• Number of treatment fractions that require adaptation

  Up to 1 year

• Percentage of subjects who experience abscopal effect

  4 weeks after any ST-SBRT fraction

• Overall survival

  Up to 1 year post initiation of study treatment

Study Arms (1)

Treatment (ST-SBRT)

EXPERIMENTAL

Patients undergo ST-SBRT on study. Patients also undergo collection of blood samples at screening and on study and undergo CT at screening, on study, and during follow up.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: Stereotactic Body Radiation Therapy

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (ST-SBRT)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Treatment (ST-SBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo ST-SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (ST-SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent of the participant and/or legally authorized representative
• Assent, when appropriate, will be obtained per institutional guidelines
• Age: \>= 18 years
• Karnofsky performance status \> 60
• Poly-metastatic disease, \> 5 lesions, and with at least one lesion \> 2.0 cm, with limited treatment options, and ineligible for or in progression under the standard systemic therapy
• Pre-screening assessment confirms that the intervention can be administered without exceeding dose constraint guidelines
• Patients with brain metastases can be included but brain metastases must be treated prior to enrollment and follow up magnetic resonance imaging (MRI) 3 months after treatment shows stable findings
• Spinal cord metastases are allowed as long as treatment with or without radiation is completed
• Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints
• Life expectancy \>= 3 months in the opinion of the treating investigators
• Off systemic therapy for at least one month prior and one month after study intervention

You may not qualify if:

• Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
• Those not eligible for SBRT after review by a radiation oncologist
• Serous medical comorbidities precluding radiotherapy
• Unable to undergo a CT scan
• Pregnant and/or breastfeeding women are excluded from this study as these agents may have the potential for teratogenic or abortifacient effects. Female patients of childbearing potentially must have a negative urine or serum pregnancy test within 72 hours prior to receiving therapy
• On active systemic therapy
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Specimen Handling; Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Yi-Jen Chen

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 17, 2023
• Study Start: April 27, 2023
• Primary Completion (Estimated): October 11, 2027
• Study Completion (Estimated): October 11, 2027
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

US (1)